Cadonilimab Injection

The English version of the instruction manual for Cadonilimab can be obtained through the DailyMed platform authorized by the US FDA and publicly available information from the National Medical Products Administration (NMPA) of China. The following is a summary of the core content based on the approval document:

1. ‌Indications and Usage‌
Indications: Cadonilimab is a PD-1/CTLA-4 bispecific antibody used to treat recurrent or metastatic cervical cancer patients who have previously undergone platinum based chemotherapy for disease progression.
This drug is the world’s first approved PD-1/CTLA-4 bispecific antibody, and has been conditionally approved by NMPA (June 2022) based on the results of a phase II clinical trial conducted in China (AK104-201), with expanded indications in 2024.
In addition, it has been approved as second-line or above treatment for recurrent or metastatic cervical cancer patients with PD-L1 positivity (CPS ≥ 1).
2. ‌Dosage and Administration‌
Recommended dose: 6 mg/kg intravenous infusion, once every 2 weeks (Q2W), infusion time should be ≥ 60 minutes.
It can be used in combination with chemotherapy or other immunotherapy, and the specific plan needs to be formulated by the doctor according to the patient’s condition.
Dose adjustment:
When there are ≥ grade 3 immune-mediated adverse reactions or infusion reactions, medication should be suspended and evaluated.
If serious uncontrollable toxicity occurs (such as severe pneumonia, colitis, myocarditis, etc.), the medication needs to be permanently discontinued.
3. ‌Mechanism of Action‌

Cadonilimab is the world’s first tetramer structured bispecific antibody to enter clinical practice, targeting both PD-1 and CTLA-4 immune checkpoints. Its design can selectively enrich in the tumor microenvironment, achieving:

Blocking the PD-1 pathway to restore T cell activity;
Inhibiting the CTLA-4 pathway to promote T cell proliferation and infiltration;
Reduce the toxicity of traditional combination immunotherapy and enhance the safety window.
4. ‌Safety and Warnings‌
Immune mediated adverse reactions: may include pneumonia, colitis, hepatitis, endocrine disorders (such as thyroid dysfunction, pituitary inflammation), nephritis, myocarditis, etc., which require timely monitoring and treatment with glucocorticoids.
Infection risk: Due to immune system activation, there may be an increased risk of infection, including severe or opportunistic infections.
Infusion related reactions: About 15% of patients report mild to moderate reactions (such as fever, chills, itching), and it is recommended to use antihistamines and antipyretics in advance.
Embryo fetal toxicity: Animal studies have shown that it can cause fetal damage. It is recommended that women with fertility potential take effective contraceptive measures during treatment and for at least 6 months after the last dose.
5. ‌Adverse Reactions‌
Common adverse reactions (≥ 20%):
Anemia, fatigue, hypothyroidism, elevated ALT/AST, rash, diarrhea, decreased appetite, and decreased neutrophils.
≥ Grade 3 adverse reactions:
Anemia (about 18%), neutropenia (about 12%), elevated transaminase (about 10%), and immune pneumonia (about 5%).
Laboratory abnormality:
Reduced blood cells, abnormal liver function, and thyroid dysfunction are common and can mostly be managed through supportive therapy.
6. ‌Drug Interactions‌
Formal drug interaction studies have not yet been conducted.
Combined use with other immunotherapy drugs (such as CTLA-4 monoclonal antibodies, LAG-3 antibodies) may significantly increase the risk of toxicity and is not recommended.
It can be used in combination with platinum containing dual drug chemotherapy regimens and has been validated for safety in phase III trials (such as the AK104-301 study).
7. ‌Pharmaceutical Information‌
Product Name: Ketanni ® （Cadonilimab）
Common name: Cadonilimab Injection
R&D company: Akeso, Inc
NMPA approval date: June 2022 (conditional approval), converted to full approval and expanded indications in 2024
Storage conditions: Refrigerate at 2-8 ° C, store away from light, do not freeze; Stable for 24 hours at 2-8 ° C and 6 hours at room temperature after reconstitution